Efficacy and safety of low-dose interleukin-2 in combination with methotrexate in patients with active rheumatoid arthritis: a randomized, double-blind, placebo-controlled phase 2 trial

Autor: Xiaoying Zhang, Miao Miao, Ruijun Zhang, Xu Liu, Xiaozhen Zhao, Miao Shao, Tian Liu, Yuebo Jin, Jiali Chen, Huixin Liu, Xia Zhang, Yun Li, Yunshan Zhou, Yue Yang, Ru Li, Haihong Yao, Yanying Liu, Chun Li, Yuhui Li, Limin Ren, Yin Su, Xiaolin Sun, Jing He, Zhanguo Li
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Signal Transduction and Targeted Therapy, Vol 7, Iss 1, Pp 1-8 (2022)
Druh dokumentu: article
ISSN: 2059-3635
DOI: 10.1038/s41392-022-00887-2
Popis: Abstract Rheumatoid arthritis (RA) is an aggressive autoimmune arthritis, and current therapies remain unsatisfactory due to low remission rate and substantially adverse effects. Low-dose interleukin-2 (Ld-IL2) is potentially a therapeutic approach to further improve the disease. This randomized, double-blind, placebo-controlled trial was undertaken to evaluate the efficacy and safety of Ld-IL2 in patients with active RA. Patients were randomly assigned (1:1) to receive Ld-IL2, defined as a dose of 1 million IU, or placebo in a 12-week trial with a 12-week follow-up. Three cycles of Ld-IL2 or placebo were administered subcutaneously every other day for 2 weeks (a total of 7 doses), followed by a 2-week break. All patients received a stable dose of methotrexate (MTX). The primary outcomes were the proportion of patients achieving the ACR20, DAS28-ESR
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